Senior Clinical Research Specialist

3 weeks ago

Irvine, California, United States Kelly Science, Engineering, Technology & Telecom Full time

Senior Clinical Research Specialist

Kelly Science and Clinical FSP is currently seeking a Senior Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Summary:

This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Responsibilities:

  • Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for
  • Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
  • May serve as the primary contact for clinical trial sites (e.g. site management)
  • Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
  • Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
  • Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
  • Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
  • Interfaces, collaborates and oversees Clinical Research Associates (CRAs)
  • Oversees and supports the development and execution of Investigator agreements and trial payments
  • Is responsible for clinical data review to prepare data for statistical analyses and publications
  • May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
  • May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
  • May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
  • Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
  • Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
  • May development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant
  • Supports project/study budget activities
  • Mentors team members
  • May perform other duties assigned as needed
  • Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
  • Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
  • Should develop a strong understanding of the pipeline, product portfolio and business needs
  • Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations.

Experience & Education:

Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

BS with at least 4 years

Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)

Clinical/medical background is a plus.

Medical device experience

Cardiovascular experience

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